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510(k) K031077

VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM by Chattanooga Group — Product Code IMG

K031077 is an FDA 510(k) premarket notification submitted by Chattanooga Group for the device "VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 11, 2003. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Chattanooga Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2003
Date Received
April 4, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5860
Review Panel
PM
Submission Type

Other clearances by Chattanooga Group

  • K090632 — COMPEX REHAB (June 1, 2009)
  • K083433 — INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 (March 18, 2009)
  • K083140 — COMPEX SPORT PLUS (February 9, 2009)
  • K070425 — VITALSTIM EXPERIA (June 11, 2007)
  • K053223 — TRITON/TRU-TRAC/TX/TRITON DTS TRACTION (February 24, 2006)
  • K051938 — TRITON/TRU-TRAC/TX TRACTION DEVICES (September 21, 2005)
  • K040662 — VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) (September 8, 2004)
  • K040285 — VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORT (April 12, 2004)
  • K031116 — VECTRA (INTELECT) EPR ULTRASOUND (December 3, 2003)
  • K023347 — VITAL STIM (December 6, 2002)

Other clearances for product code IMG

  • K244041 — Ultrasound Therapy Workstation (XMS-UET2) (October 7, 2025)
  • K153559 — OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy Sy (August 26, 2016)
  • K150436 — ComboRehab (November 13, 2015)
  • K150353 — BTL-4000 (November 13, 2015)
  • K120217 — SONICSTIMU COMBO THERAPEUTIC DEVICE (November 21, 2012)
  • K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM (August 7, 2012)
  • K102524 — FUTURA (November 3, 2011)
  • K111482 — SONICATOR PLUS 920 (August 25, 2011)
  • K102190 — WINSTIM (March 17, 2011)
  • K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE (January 14, 2010)

FDA data resources